In 2003 the EU Commission requested to evaluate the safety of Indigofera Tinctoria in cosmetic products. Find out the SCCS's final opinion in this article!
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COVID-19 PPE WEBINAR: How to sell PPE in Europe?
Due to the outbreak of the COVID-19 in Europe, the European Union was registering increasing shortages of Face Masks and other PPE-related equipment; PPE manufacturers needed to move fast to secure the supply of such equipment on the European market.
Belgium has identified a list of COVID-19 critical devices, which devices are on the list?
The Belgian FAMHP issued a guidance document listing critical devices for health systems during the Covid-19 pandemic. Find out what is on the list here!
The upload of software into radio equipment – Commission’s Clarifications
All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
Request for scientific opinions of SCCS: certain ingredients under review
The Eu Commission has requested the opinion of the SCCS regarding the safety of several cosmetic ingredients. Find out which ones in this article!
New restrictions for Salicylic acid
The European Commission has issued a Corrigendum to its Cosmetic Regulation concerning Salicylic acid. Find out all the details in this article.
In Vitro Diagnostic Devices: main steps to compliance and frequently asked questions
What is the path to EU compliance for IVDs? Find the answers to most common questions in this article and clear all your doubts!
EU Commission guidelines on Covid-19 tests’ performance
In order to face the lack of reliable Covid-19 test devices, the European Commission published the required performance criteria. Read here all the details!
MDCG issued Guidance on clinical data of legacy devices (01/03)
The MDCG has issued a Guide for manufacturers and Notified Bodies on Clinical Evidence. Learn all the clarifications on legacy devices in this article.
Guidance on Regulatory Requirements for Ventilators and Related Accessories
The Medical Device Coordination Group issued a guidance on how to place ventilators on the EU market during the Covid-19 pandemic. Find out all the details.